a study to assess the relative bioavailability and safety of different formulations of azd4831 in fasted state in healthy volunteers.

Conditions: Healthy Volunteers

Summary: a study to assess the relative bioavailability and safety of different formulations of azd4831 in fasted state in healthy volunteers.

this study will be a randomized, open-label, 2-period, 2-treatment, single-dose, single-center, crossover study conducted at a single clinical unit. a total of 30 healthy male and female participants will be randomized to ensure that at least 26 participants are evaluable . the study will comprise of: * a screening period of maximum 28 days. * period 1: single oral dose azd4831 formulation a or b on day 1. * period 2: single oral dose azd4831 formulation a or b on day 1. * a final follow-up visit after the last administration of investigational medicinal product (imp) (14 days \[+ 3 days\] post final dose). there will be a minimum washout period of at least 14 days from the first dose of azd4831. participants will receive single doses of azd4831 (2 different formulations) on 2 occasions under fasted conditions. participants will be given the following treatments and randomly assigned to the treatment sequence(s): ab, ba * treatment 1 (reference), azd4831 formulation a, oral dosage form), fasted. * treatment 2 (test), azd4831 formulation b, oral dosage from), fasted.

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures. * male participants must adhere to the contraception methods. * females must have a negative pregnancy test at screening and on admission to the clinical unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: 1. postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (fsh) levels in the postmenopausal range. 2. documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. * have a body mass index (bmi) between 18.5 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg inclusive at screening. exclusion criteria: * any clinically significant abnormalities on 12-lead electrocardiogram (ecg) at the screening visit, as judged by the investigator. * any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of imp. * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * known or suspected gilbert's syndrome. * history or ongoing allergy/hypersensitivity to drugs (including, but not limited to rash, angioedema, acute urticaria). * use of drugs with enzyme-inducing properties such as st john's wort within 3 weeks before the first administration of azd4831. * participants who previously received azd4831. * any of the following signs or confirmation of covid-19 infection: 1. participant has a positive sars-cov-2 reverse transcription-pcr test result within 2 weeks before the screening visit or between the screening visit and randomization. 2. clinical signs and symptoms consistent with covid-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) 2 weeks before the screening visit or between the screening visit and randomization. 3. participant has been hospitalized with covid-19 infection within the last 3 months.

Keywords: relative bioavailability azd4831 heart failure with preserved ejection fraction cardiovascular disease